PJC

Newborn Screening Specimen Collection Paper

Product code

PJC

Device name

Newborn Screening Specimen Collection Paper

Device class

Class 2

21 CFR

21 CFR 862.1675

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).